IMPLANT FOR THE TREATMENT AND/OR FOR REPLACEMENT OF AN INFLAMMED, THROMBOSED OR DEGENERATED HEART VALVE

Abstract

The invention relates to an implant (1) for treating and/or for replacing a heart valve (100) diseased by an inflammation and/or infection, wherein the implant (1) has a catching device (2) which, in a compressed state, can be introduced in a minimally invasive manner into the body of the patient, and which can be expanded at the implantation site on the diseased heart valve (100), wherein the catching device (2) is designed, at least in the implanted and expanded state, to compartmentalise tissue changes or tissue deposits (101), in particular in the form of heart valve vegetation or deposits, in particular by using the catching device (2) to engage around and/or receive at least regions of the tissue change or deposit (101).

Claims

1. An implant for the treatment and/or replacement of a diseased inflamed and/or infected heart valve, wherein the implant comprises a capture device which is able to be introduced into a patient's body in a compressed state in minimally invasive manner and expanded at an implantation site on the diseased heart valve, wherein the capture device, at least in an implanted and expanded state, is designed to compartmentalize tissue changes or tissue deposits in the form of heart valve vegetation or deposits by the capture device at least partially grasping and/or capturing the tissue change or deposit, wherein the capture device comprises an anchoring structure for the fixation and/or positioning of the capture device at the implantation site, and wherein the capture device comprises a capturing structure connectable to the heart valve which extends downstream, as viewed in the direction of the blood flow, from the anchoring structure into a vessel connected to the diseased heart valve in terms of flow and exhibits at least one clamping area in the expanded state which is designed to interact with at least one heart valve leaflet of the diseased heart valve in the expanded and implanted state of the capture device such that at least one heart valve leaflet is pressed toward a vascular wall and at least partially enclosed by the capture device.

2. (canceled)

3. The implant according to claim 1, wherein the at least one clamping area comprises at least one clamping arm or clamping bracket designed to at least partly expand radially upon the expansion of the capture device in the implantation site, wherein the clamping area designed to interact at a distal end region on the far side from the anchoring structure with a further abutment structure to be implanted.

4. The implant according to claim 1, wherein the implant further comprises an expandable replacement heart valve which can be introduced into the patient's body in a compressed state in minimally invasive manner and is expandable at the implantation site on the diseased heart valve such that the replacement heart valve assumes the function of a native heart valve, wherein the replacement heart valve and the capture device are connected or connectable to one another by means of a common anchoring structure designed to be positioned and fixed in an area of roots of the heart valve leaflets of the native heart valve.

5. The implant according to claim 4, wherein the implant is designed to expand incrementally over time in the implantation site on the diseased native heart valve, wherein the capture device expands in a first step and the replacement heart valve expands in a second step; or wherein the implant is designed to expand incrementally over time in the implantation site on the diseased native heart valve, wherein the replacement heart valve expands in a first step and the capture device expands in a second step.

6. The implant according to claim 1, wherein the implant further comprises a structure able to be implanted separately from the capture device and which exhibits a substantially annular self-expanding structure and is insertable into pockets of a native heart valve and serves as abutment for the capture device or the clamping area of the implant.

7. The implant according to, claim 1, wherein the implant and/or an abutment structure allocated to the implant is/are designed to release antimicrobial, antithrombotic or cell growth-inhibiting active substances at least in the implanted state.

8. The implant according to claim 7, wherein for the release of the active substances, the capture device and/or a replacement heart valve that may be part of the implant and/or an abutment structure allocated to the implant has a coating of the active substances.

9. The implant according to claim 7, wherein for the release of the active substances, the implant or components of the implant and/or the abutment structure allocated to the implant comprise at least one bioresorbable structure exhibiting a fibrous, non-woven and/or membrane structure; and/or wherein the implant or components of the implant and/or the abutment structure allocated to the implant comprise at least one active substance-releasing area which is at least partially coated or covered by at least one polymer material and designed to control the direction of release of the active substance and/or at least greatly reduce a release of the active substance toward the at least one polymer material used for the coating.

10. A catheter for introducing the implant of claim 1 into a body of a patient, wherein the catheter has a catheter tip able to be manipulated via a handle of the catheter such that the implant can be released from the catheter tip incrementally.

11. A system for the treatment or the replacement of an inflamed, thrombosed or degenerated heart valve comprising the implant according to claim 1 and a catheter, wherein the catheter has a catheter tip able to be manipulated via a handle of the catheter such that the implant can be released from the catheter tip incrementally, and wherein the implant is designed to be able to be accommodated in the catheter tip when the implant is extended in the longitudinal direction and in a reduced state relative to the radial direction of the implant, and wherein the catheter tip is designed to accommodate the implant when the implant is extended in the longitudinal direction and in the reduced state relative to the radial direction of the implant.

12. The system according to claim 11, wherein the system comprises an additional and/or independent at least substantially annular, self-expanding implant which is designed to serve as an abutment for the implant of claim 1 and which is able to be folded by radial stretching and accommodated in folded form in the catheter and implanted at the implantation site such that in the implanted state of the implant, at least some areas of at least one valve leaflet of the heart valve to be treated can be accommodated between the implant of claim 1 and the additional and/or independent implant.

13. The system according to claim 12, wherein the additional and/or independent implant is designed to be receivable in the catheter tip in the compressed state such that the additional and/or independent implant in the compressed state is not aligned coaxially but rather orthogonally to the catheter tip axis and is also able to be incrementally released at the implantation site by means of one or more pressure-resistant connections.

14. A method for the treatment or the replacement of an inflamed, thrombosed, or degenerated heart valve, wherein the method comprises the method step of compartmentalizing tissue changes or tissue deposits in the form of heart valve vegetation or deposits, and by the tissue changes or tissue deposits being at least partially captured and/or grasped by a capture device.

15. The method according to claim 14, wherein the method further comprises the method step of implanting a replacement heart valve to replace the diseased native heart valve, wherein the step of compartmentalizing and the step of implanting the replacement heart valve are preferably performed chronologically sequentially; and/or wherein the method further comprises the method step of releasing antimicrobial, antithrombotic and cell growth-inhibiting active substances, wherein the release ensues in situ.

Description

[0058] The following will reference the accompanying drawings in describing exemplary embodiments of the invention in greater detail.

[0059] Shown are:

[0060] FIGS. 1A and 1B a schematic and sectional view of an endocarditis-diseased aortic valve with bacterial vegetation, wherein FIG. 1A shows the aortic valve in the closed state and FIG. 1B shows the aortic valve in the open state;

[0061] FIGS. 2A and 2B a schematic and sectional view of the inserting (FIG. 2A) and final position (FIG. 2B) of an active substance-coated implant serving as an abutment for a further stent;

[0062] FIG. 2C to 2F a schematic and partially sectioned view (FIG. 2C to 2E) or respectively sectioned view (FIG. 2F) of an active substance-coated implant serving as an abutment for a further stent during introduction orthogonal to the catheter axis, pushing out of the catheter, and placement behind the aortic valve leaflets;

[0063] FIG. 3A to 3F a schematic and sectional view of the insertion, placement and release of a first exemplary embodiment for the treatment and replacement of an endocarditis-diseased aortic valve;

[0064] FIG. 4A to 4D a schematic and sectional view of the insertion, placement and release of a second exemplary embodiment for the treatment and replacement of an endocarditis-diseased aortic valve; and

[0065] FIG. 5A to 5E a schematic and sectional view of the insertion, placement and release of a third exemplary embodiment for the treatment and replacement of an endocarditis-diseased aortic valve.

[0066] FIG. 1 shows the anatomy of an endocarditis-diseased aortic valve 100 in schematic and sectional view, wherein the aortic valve is depicted closed in FIG. 1A and the aortic valve is depicted open in FIG. 1B.

[0067] Briefly summarized, the aortic valve 100 is one of the four valves of the heart. Located in the aorta 102 directly at its root from the left ventricle, it prevents the reflux of blood at the beginning of the heart's relaxation phase (diastole).

[0068] As a semilunar valve, the aortic valve 100 consists in most cases of three crescent-shaped pockets. The valve lies with its bulges (sinuses) at the origin of the ascending aorta 102 (aorta ascendens). In the German language, the pockets are designated according to the outflow of the two coronary arteries from the associated sinus: right coronary pocket at the outflow of the right coronary artery, left coronary pocket at the outflow of the left coronary artery and acoronary pocket (sinus without outgoing coronary artery). With an aortic valve insufficiency and/or aortic valve endocarditis, it is often necessary to replace the native aortic valve 100 with a replacement heart valve 10.

[0069] Aortic valve endocarditis can be caused by numerous microorganisms. Particularly gram-positive bacterial species such as e.g. streptococci, enterococci and staphylococci frequently occur as human-pathogenic germs in infective endocarditis. If they colonize the endocardium, e.g. the native aortic valve 100, in the course of bacteremia, infective endocarditis develops, which is an inflammation of the inner lining of the heart (endocardium). If left untreated, the course of the disease is usually fatal.

[0070] In the context of bacterial endocarditis, tissue deposits 101 are further formed on the heart valves 100 by bacteria, their metabolites as well as other parts of the human organism. Such tissue deposits 101 are also referred to as “heart valve vegetation.” So-called non-bacterial thrombotic vegetation can be regarded as being a prerequisite for bacterial colonization. These are thrombocytes which attach to damaged endothelium of the heart valves 100.

[0071] In heart valve endocarditis, the heart valve vegetation 101 forms in particular as fibrous or membranous structures on the native heart valves 100, which can be up to 25 mm long.

[0072] The risk here is that the vegetation 101 will be torn away by the pumping heart and clog blood vessels in the organs as it flows through the bloodstream. Stroke or renal embolism are among the feared resulting complications, whereby stroke is feared the most since it carries a high risk of inflammation of the brain or cerebral membrane.

[0073] A further complication is the risk of germs being spread to other organs, where abscesses can then form. Acute organ failure can occur (for example kidney, liver and/or lung failure) as a result of blood poisoning and septic or toxic shock from toxigenic bacteria.

[0074] In order to minimize the risk posed by heart valve vegetation 101 when treating aortic valve endocarditis, the invention provides for appropriately compartmentalizing the heart valve vegetation 101 within the scope of replacing an endocarditis-diseased heart valve 100. This can preferably take place prior to replacing the native heart valve 100 with a prosthetic heart valve 10 or else during the replacement or following replacement of the diseased native heart valve 100.

[0075] An implant 1 comprising a capture device 2 is used for the compartmentalization of the heart valve vegetation 101, wherein said capture device 2 can be introduced into the patient's body in a compressed state in minimally invasive manner and expanded at the implantation site on the diseased heart valve. The capture device 2 is designed to at least partially grasp and/or capture and thus compartmentalize tissue deposits 101 (heart valve vegetation), at least in the implanted and expanded state.

[0076] In the embodiments shown in FIG. 3A to 3F, FIG. 4A to 4D and FIG. 5A to 5E, the implant 1 with the capture device 2 further comprises a corresponding replacement heart valve 10, which is either a self-expandable or balloon-expandable replacement valve able to be introduced into the patient's body in a minimally invasive manner in a compressed state and expanded at the implantation site on the diseased heart valve 100 such that the replacement heart valve 10 at least substantially assumes the function of a native heart valve 100.

[0077] The replacement heart valve 10 is preferably allocated a stent 3 in order to support and bear the replacement heart valve 10. The stent 3 allocated to the replacement valve 10 is designed to radially displace the diseased native heart valve 100 or the heart valve leaflets 103 of the diseased native heart valve 100 respectively in order for the replacement heart valve 10 to be stretched out in its place and ensure unfailing valve function during the systole and diastole of the heart.

[0078] The stent 3 allocated to the replacement valve 10 is in particular structurally designed so as to provide secure retention for the replacement heart valve 10 during the periodic beating of the heart so that the implant 1 cannot dislodge from the biological tissue, in particular from the vascular wall, and be flushed out of the implantation site due to changing pressure conditions in the heart.

[0079] The at least one stent 3 allocated to the replacement valve 10 preferably further serves as an anchoring structure for the capture device 2 of the implant 1. The use of multiple stents 3 or stent systems suitably connected or connectable to one another for these functions (carrier and supporting structure of the replacement heart valve 10 and anchoring structure of the capture device 2) is however of course also conceivable in this context.

[0080] The stent or stents 3 of the inventive implant 1 can be expanded by balloon expansion using a balloon catheter and positioned at the implantation site. The stent 3, which is compressed and encapsulated within the catheter, is thereby expanded by a catheter balloon to be filled with liquid or gas.

[0081] Alternatively, the at least one stent 3 of the inventive implant 1 can be a self-expandable stent 3. In particular, the stent 3 consists of a shape memory alloy, preferably nitinol, to that end. In addition to the shape memory effect at a specific transition temperature which is close to body temperature, nitinol also exhibits superelasticity, biocompatibility and corrosion resistance. Nitinol is thus already widely used in medical technology. Particularly the superelasticity is advantageous with respect to a stent's compressed form of delivery in the transcatheter method and the expansion at the implantation site.

[0082] In addition to the two separately executed expansion processes, a combination of both processes is likewise possible. In particular, the radial pretension of the at least one stent 3 of the implant 1 can be additionally further increased after the self-expansion by a balloon expansion, whereby a higher stability of the inventive implant 1 in the implanted state is in turn achieved.

[0083] The replacement heart valve 10 secured to the at least one stent 3 can be a pericardial valve, a biological heart valve (for example pig or cattle), an artificial heart valve 100, preferably of biocompatible materials, or a comparable implant or transplant suitable for replacing an endocarditis-diseased heart valve 100. The inventive implant 1 thus offers the advantage of the replacement heart valve 10 being able to have the optimal design depending on the patient-specific conditions.

[0084] The replacement heart valve 10 comprises at least two heart valve leaflets 103. With regard to the replacement of a three-part heart valve 100, usage with more than two, in particular three, leaflets 103 is also conceivable. The use of the inventive implant 1 is thus not limited just to the treatment and replacement of one endocarditis-diseased native aortic valve 100, particularly not by the number of leaflets 103.

[0085] In their intended use, the leaflets 103 of the replacement heart valve 10 have two positions in particular, which they assume during the systole and diastole of the heart. With the objective of mimicking a native heart valve 100 as a biological model, an equivalent conferring of the functionality of the leaflets 103 as per the biological model is accordingly also conceivable for the replacement of the other native heart valves 100. In a first position of the leaflets 103, during the diastole of the heart, the flow connection between the left ventricle and the aorta 102 is completely closed so as to prevent blood reflux. The commissures of the leaflets 103; i.e. the inner vascular edges, are thereby in contact with one another. During the systole of the heart, the leaflets 103 assume a second, opened position so that the blood can be pumped from the ventricle into the aorta 102. The commissures of the leaflets 103 have no contact with one another in this second position.

[0086] The capture device 2 of the inventive implant 1 can exhibit an anchoring structure in the form of a stent 3, wherein this stent 3 can serve as a carrier and supporting structure for the replacement heart valve 10. The capture device 2 can in this way be appropriately fixed and positioned in the implantation site.

[0087] A capturing structure 4 is connected to the anchoring structure 3 which when viewed in the direction of the blood flow, extends downstream from the anchoring structure 3 into a vessel 102 connected to the diseased heart valve 100 in terms of flow, in particular into the aorta, and exhibits at least one clamping area 5 in the expanded state which is designed to interact with at least one heart valve leaflet 103 of the diseased heart valve 100 in the expanded and implanted state of the capture device 2 such that the at least one heart valve leaflet 103 is positioned between the anchoring structure 3 and the capturing structure 4.

[0088] The clamping area 5 of the capture device 2 can have at least one clamping arm or clamping bracket designed to expand at least in part in the radial direction upon the capture device 2 being expanded in the implantation site.

[0089] According to embodiments, the clamping area 5 can exhibit at least one area 6 directed at least substantially toward the anchoring structure 3 at a distal end region facing away from the anchoring structure 3 in order to optimize a grasping or capturing of the heart valve vegetation 101 and non-positively or positively interact with an inventive structure 7 (e.g. abutment implant).

[0090] When treating or respectively replacing an endocarditis-diseased heart valve 100, in particular an aortic valve 100, a structure 7 can first be inserted prior to the introduction of the implant 1 with the capture device 2 and the replacement heart valve 10 which is of a substantially annular structure and is for example supported in the pockets of the native heart valve 100 and can fill them. This structure 7 serves as an abutment for the implant 1 to then be subsequently implanted. Preferably, the annular abutment structure 7 exhibits a longitudinal shape and height which do not block the openings of the coronary arteries in the implanted state.

[0091] The inventive implant 1 can—as depicted in the drawings—be incrementally implanted as one coherent system over the course of one insertion procedure. It is however also conceivable to implant the implant 1 and the structure 7 one after the other in a series of separate insertion procedures and in particular then; i.e. in the implanted state, connect the components of the implant 1, in particular the capture device 2 and the replacement heart valve 10 or respectively a stent allocated to the replacement heart valve 10.

[0092] In the embodiment shown in FIG. 3A to 3F, the implant is incrementally implanted over time, whereby the capture device is expanded and pushed downward and non-positively or positively connected to the abutment implant 7 in a first step and the heart valve is expanded and released in a second step.

[0093] In the embodiment shown in FIG. 4A to FIG. 4D, the implant 1 is incrementally expanded sequentially over time, whereby the replacement heart valve 10 is implanted and expanded in a first step and the capture device 2 expanded in a subsequent second step.

[0094] In contrast, the insertion procedure shown in FIG. 5A to FIG. 5E provides for the capture device 2 to be expanded first and then the replacement heart valve 10.

[0095] With both insertion procedures, the implant 1 accommodated in the compressed state in a catheter tip of an catheter introduction system 20 is advanced to the implantation site via a transfemoral approach. In principle, however, it is also conceivable for the implant 1 to be introduced via a transapical route; i.e. coming from the apex of the heart.

[0096] For implantation, preferably the annular abutment 7 is first inserted into the pockets of the native heart valve 100. However, the invention is not limited to the provision of such an abutment 7.

[0097] One embodiment of the abutment implant 7 provides for its coaxial introduction into the catheter; i.e. with radial compression and thereby axial extension over a catheter, and then its radial (self-)expansion. Another embodiment of the abutment implant 7 provides for its introduction not coaxially but rather at least substantially folded and orthogonal to the catheter axis in order for a larger volume to be introduced with the same catheter diameter.

[0098] The inventive implant 1 is thereafter implanted via a catheter 20, the catheter tip of which accommodates the implant 1 in a compressed state. Preferably, the implant 1 is accommodated in the catheter tip of the catheter introduction system 20 in a state which is stretched in the longitudinal direction of the implant 1 and reduced with respect to the radial direction of the implant 1 so as to be able to minimize the diameter of the catheter system 20.

[0099] Moreover, a guide wire 21 is preferably used in the implantation in order to make the introduction of the catheter easier and safer.

[0100] In the insertion procedure shown in FIG. 4A to 4C, the catheter tip is moved as far toward the ventricle that the replacement heart valve 10 accommodated in the catheter tip is at the height of the native heart valve 100. Then follows the expansion of a stent 3 allocated to the replacement heart valve 10 to which the replacement heart valve 10 is suitably secured.

[0101] This ensues by the catheter tip being appropriately manipulated in order to move a sleeve-like region which at least partly forms the catheter tip and holds the implant 1 in the compressed state in the proximal direction. As a result of this displacement, a part of the implant 1 is released, particularly the stent 3 allocated to the replacement heart valve 10 with the affixed replacement heart valve 10.

[0102] When the stent 3 allocated to the replacement heart valve 10 expands, it presses the native heart valve leaflets 103 of the diseased heart valve 100 in the radial direction, whereby the annular structure 7 optionally inserted previously into the pockets of the native heart valve 100 serves as an abutment.

[0103] In the state shown in FIG. 4B, it is in particular possible to check the proper positioning of the replacement heart valve 10 as well as its unfailing functionality. If it is thereby shown that the replacement heart valve 10 is not positioned in the right place, this can easily be corrected without any difficulty. On the other hand, should the replacement heart valve 10 not be functioning properly, it can be returned to the catheter sleeve and the implant 1 removed again from the patient's body.

[0104] Once the correct positioning and functioning of the replacement heart valve 10 have been verified, the capture device 2 can then be released, and that by distally displacing a corresponding second sleeve-like region of the catheter tip. The capture device 2 is preferably “programmed” such that it encloses the heart valve vegetation 101 during its expansion and thus takes it out of the main bloodstream.

[0105] In the alternative insertion procedures shown in FIG. 3A to FIG. 3F and FIG. 5A to FIG. 5E, the capture device 2 is first released from the catheter tip. The replacement heart valve 10, or the stent 3 allocated to the replacement heart valve 10 respectively, is then released.

[0106] This insertion procedure has the advantage of the heart valve vegetation 101 already being compartmentalized before the replacement heart valve 10 expands, although the insertion procedure shown in FIG. 5A to 5E necessitates the catheter tip being inserted further in the direction of the ventricle.

[0107] In the insertion procedures shown in FIG. 3A to FIG. 3F and in FIG. 5A to 5E, a clamping area 5 initially expands upon the capture device 2 being released, wherein this clamping area 5 is connected to an anchoring structure 3 of the (not yet implanted) implant 1.

[0108] Able to be seen from the depictions in FIGS. 5B and 5C is that the clamping area 5 exhibits at least one area 6 at a distal end region on the far side from the anchoring structure 3 which is substantially directed toward the anchoring structure 3, this considerably simplifying the capture and enclosure of the heart valve vegetation 101.

[0109] After the capture device 2 has been fully released and expanded (see FIG. 5D as well as FIG. 3C), the replacement heart valve 10, or a stent 3 allocated to the replacement heart valve 10 respectively, is released by manipulating a front sleeve-shaped region of the catheter tip in the proximal direction.

[0110] The implant 1 and/or the annular abutment 7 inserted into the pockets of the native heart valve 100 is/are in particular designed to release one or more active substances, in particular antibacterial, antithrombotic and cell growth-inhibiting compounds, in situ.

[0111] The invention is not limited to the embodiments depicted in the drawings but rather yields from an integrated overall consideration of all the features disclosed herein.

LIST OF REFERENCE NUMERALS

[0112] 1 implant [0113] 2 capture device [0114] 3 stent [0115] 4 capturing structure [0116] 5 clamping area [0117] 6 capturing structure area directed toward the abutment structure [0118] 7 abutment implant/abutment structure [0119] 10 prosthetic heart valve [0120] 20 catheter [0121] 21 guide wire [0122] 100 heart valve [0123] 101 heart valve vegetation/tissue deposit [0124] 102 aorta [0125] 103 (native) heart valve leaflet